[Federal Register: April 14, 2004 (Volume 69, Number 72)]
[Rules and Regulations]
[Page 19765-19766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap04-8]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 2002N-0278]
Prior Notice of Imported Food Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002; Joint Food and
Drug Administration-Customs and Border Protection Plan for Increasing
Integration and Assessing the Coordination of Prior Notice Timeframes;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Availability of joint plan.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and Customs and Border
Protection (CBP) announce the availability of a plan entitled ``Joint
FDA-CBP Plan for Increasing Integration and Assessing the Coordination
of Prior Notice Timeframes.'' The plan, which includes an assessment
schedule, describes the process by which FDA and CBP intend to increase
integration and examine whether we could amend the timeframe
requirements in FDA's prior notice interim final rule (IFR) to have the
same advanced notice timeframes for arrivals by land via road or rail,
or arrival via air that are currently in CBP's advance electronic
information rule.
DATES: Submit written or electronic comments by May 14, 2004.
ADDRESSES: Submit written requests for single copies of the plan to the
Office of Regional Operations (HFC-100), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed
adhesive label to assist that office in processing your request or
include a fax number to which it may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the plan. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Joseph McCallion, Division of Import
Operations and Policy (HFC-170), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-6553.
SUPPLEMENTARY INFORMATION:
I. Background
A. FDA Prior Notice Interim Final Rule
On October 10, 2003, FDA issued an IFR (the prior notice IFR) (68
FR 58974) to implement new section 801(m) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), added by section
307 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act), which required prior
notification of imported food to begin on December 12, 2003. The prior
notice IFR requires the submission to FDA of prior notice of food,
including animal feed, that is imported or offered for import into the
United States. The prior notice IFR requires that prior notice be
submitted to FDA electronically via either CBP's Automated Broker
Interface (ABI) of the Automated Commercial System (ACS) or the FDA
Prior Notice System Interface (FDA PN System Interface) (21 CFR 1.280).
Food imported or offered for import without adequate prior notice is
subject to refusal and, if refused, must be held (21 CFR 1.283).
Under section 801(m)(2)(A) of the FD&C Act, FDA is to choose
timeframes that ``shall be no less than the minimum amount of time
necessary for the Secretary [of Health and Human Services] to receive,
review, and appropriately respond to such notification * * *.'' Using
this standard, the prior notice IFR requires that the information must
be submitted and confirmed electronically as facially complete by FDA
for review no more than 5 days and no less than 8 hours (for food
arriving by water), 4 hours (for food arriving by air or land/rail),
and 2 hours (for food arriving by land/road) before the food arrives at
the port of arrival (21 CFR 1.279). However, when we issued the prior
notice IFR, FDA was committed to exploring ways to increase integration
of advance electronic notification processes with CBP and reduce prior
notice timeframes further. Indeed, we stated in the preamble of the
prior notice IFR (68 FR 58974 at 58995) that, by March 12, 2004, FDA
and CBP would publish a plan, including an implementation schedule, to
achieve the goal of a uniform, integrated system, and to coordinate
timeframes for import prior notice information while fulfilling the
Bioterrorism Act mandates for air and truck modes of transportation
with timeframes finalized by CBP when they finalize their rule entitled
``Required Advance Electronic Presentation of Cargo Information'' (the
Advance Electronic Information Rule).
For this reason, as well as to obtain comments on other aspects of
the prior notice rulemaking, we issued the IFR with an opportunity for
public comment for 75 days. Moreover, to ensure that those who comment
on the prior notice IFR would have had the benefit of our experience
with the systems, timeframes, and data elements, FDA also stated that
it intended to reopen the comment period for an additional 30 days in
March 2004, coinciding with the issuance of the plan by FDA and CBP
relating to timeframes.
B. CBP Advance Electronic Information Rule
On December 5, 2003, CBP issued the Advance Electronic Information
Rule (68 FR 68140), which requires CBP to receive, by way of a CBP-
approved electronic data interchange system, information pertaining to
cargo before the cargo is either brought into or sent from the United
States by any mode of commercial transportation (sea, air, rail, or
truck). The cargo information required is that which is reasonably
necessary to enable high-risk shipments to be identified for purposes
of ensuring cargo safety and security and preventing smuggling under
the laws enforced and administered by CBP. The Advance Electronic
Information Rule implements the provisions of section 343(a) of the
Trade Act of 2002, as amended by the Maritime Transportation Security
Act of 2002.
The relevant timeframes provided in the Advance Electronic
Information Rule are as follows:
For arrival by land via road at ports that are
fully equipped to accommodate CBP's Advance Electronic Information
Rule, no later than 1 hour prior to the arrival of the truck at the
border, or for
[[Page 19766]]
Free and Secure Trade/Customs-Trade Partnership Against Terrorism
(FAST/C-TPAT) participants, 30 minutes;
For arrival by land via rail at ports that are
fully equipped to accommodate CBP's Advance Electronic Information
Rule, no later than 2 hours prior to the arrival of the train at the
border;
For arrival by air, no later than the departure
time (``wheels up'') of the aircraft from any foreign port or place in
North America, including locations in Mexico, Central America, South
America (from north of the Equator only), the Caribbean, and Bermuda,
and from other areas into ports that are fully equipped to accommodate
CBP's Advance Electronic Information Rule no later than 4 hours prior
to the arrival of the aircraft in the United States.
II. Joint FDA-CBP Plan for Increasing Integration and Assessing the
Coordination of Prior Notice Timeframes
After consultation, FDA and CBP have developed a plan to increase
integration and assess whether FDA can adopt reduced timeframes. As set
out in the plan, the agencies intend to assess whether FDA can meet its
statutory mandate under section 801(m)(2)(A) of the FD&C Act if prior
notice is received and confirmed electronically by FDA for review with
reduced timeframes, including those adopted by CBP by mode of
transportation listed in the following paragraphs, no fewer than:
1 hour before arrival by land by road, or 30
minutes for participants in FAST/C-TPAT;
2 hours before arrival by land by rail;
By ``wheels up'' for flights originating in
North and Central America, South America (north of the Equator only),
the Caribbean, and Bermuda; otherwise 4 hours before arrival by air.
As noted previously, section 801(m)(2)(A) of the FD&C Act states
that FDA shall by regulation prescribe the time of submission of the
notification in advance of importation or the offering of the food for
import, which period shall be no less than the minimum amount of time
necessary for the Secretary to receive, review, and appropriately
respond to such notification, and any timeframe FDA adopts in the final
rule must be justified under this standard.
III. Comments
Elsewhere in this issue of the Federal Register, we are reopening
the comment period on the prior notice IFR. To be considered part of
the rulemaking record, interested persons must submit to the Division
of Dockets Management (see ADDRESSES) written or electronic comments on
the plan as indicated in the DATES section of this document. Two copies
of any mailed comments are to be submitted by commenting entities;
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
plan and comments FDA has received may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Interested persons who wish to submit general comments on the prior
notice IFR should consult the document reopening the comment period
that is published elsewhere in this issue of the Federal Register.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/bioterrorism/bioact.html.
Dated: March 24, 2004.
Lester M. Crawford,
Acting Commissioner for Food and Drugs.
Dated: April 6, 2004.
Robert C. Bonner,
Commissioner, Customs and Border Protection.
[FR Doc. 04-8515 Filed 4-9-04; 4:51 pm]
BILLING CODE 4160-01-S